Connective Tissue Diseases and Lung Manifestations

Systemic Sclerosis Clinical Trial

— Colipris  

Official title:

Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095351
• Other study ID #: 20190506-2003
• Status: Recruiting
• Start date: December 9, 2019
• Est. completion date: October 1, 2034

Study information

• Verified date: September 2019
• Source: Medical University Innsbruck
• Contact: Magdalena Aichner, MD
• Phone: +43 512-504-83765
• Email: magdalena.aichner[@]i-med.ac.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Despite a number of prospective studies already initiated in the past years, the current epidemiology and course of interstitial lung disease (ILD) and pulmonary hypertension (PH) in patients with connective tissue disease (CTD) is still not well defined, particularly regarding its prevalence, incidence and the management of a broad spectrum of disease presentations.

Major challenges include the identification of patients with progressive disease, the appropriate time point of therapeutic intervention and the underlying driver of disease (inflammatory or pro-fibrotic stimulus or both?).

To address these issues in Western Austria, a progressive registry of patients with CTD exploring routine clinical and pathophysiological characteristics of ILD and PH will be conducted. This multidisciplinary, prospective and observational registry aims to collect comprehensive clinical data on incidence, prevalence and course of disease regarding all PH and ILD presentations in a real-world setting.

Description:

Specifically, this registry will collect demographic data, disease-related clinical data, routine laboratory values (including antibody-profile and iron status), diagnostic procedures, significant comorbidities, therapeutic managements (e.g. thoracic ultrasound, HRCT), and disease outcomes over 10 years.

In addition, blood biobank samples for translational research will be collected in a subgroup of patients with systemic sclerosis over serial time points to study the systemic inflammatory and profibrotic phenotype of patients. In summary, this registry will monitor the disease course of pulmonary manifestations of patients with CTD and may be hypothesis-generating and provide new insights in underlying inflammatory/pro-fibrotic patterns.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2034
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria are adult patients (=18 years) diagnosed with CTD with signed informed consent.

Exclusion Criteria:

• Exclusion criteria are patients with a serious co-morbidity interfering with the course of interstitial lung disease or pulmonary hypertension.

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Diagnostic Test:
• Pulmonary function test
Spirometry or plethysmography, measurement of diffusion capacity
• Imaging
Thoracic ultrasound, HRCT as scheduled within routine clinical examinations, echocardiography

Biological:
• Blood sampling
Standard laboratory test for CTDs as part of routine clinical examination

Locations

Country	Name	City	State
Austria	Medical University Innsbruck, Department of Internal Medicine II	Innsbruck

Sponsors (2)

Lead Sponsor	Collaborator
Medical University Innsbruck	Boehringer Ingelheim

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decline in forced vital capacity	Absolute decline from baseline in forced vital capacity percent predicted. Lung function tests are performed by a trained professional.	1 year
Primary	Increase in the modified Rodnan Skin Score	Change in the modified Rodnan Skin Score from baseline of >5 Points assessed by a trained professional	1 year
Primary	Decline in Diffusion capacity for carbon monoxide	Absolute decline from baseline in diffusion capacity for carbon monoxide in percent measured. Lung function tests are performed by a trained professional.	1 year